K242297
- 510(k) number
- K242297
- Device name
- Reform Pedicle Screw System
- Applicant
- Precision Spine, Inc. MS · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-12-17
- Date received
- 2024-08-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242297.pdf
Official FDA record: K242297
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.